Hi Katie, from my perspective, implementing real-time monitoring of continuous processes using Process Analytical Technology (PAT) tools alongside automation is the most effective method to ensure consistent quality throughout the API manufacturing process. However it is not easy, especially considering the complexity of API manufacturing. Also, during CM run, various instances may arise that disrupt either component within the entire manufacturing system, posing challenges in effectively managing these disturbances. Establishing a robust control strategy for the API Continuous Manufacturing process is crucial in addressing such issues. I am keen to learn from our fellow experts about additional measures they consider valuable in maintaining quality and addressing disruptions.
For certain reactions, we often get to the discussion of "should we have PAT in manufacturing?". After listing some pros and cons, I believe it comes down to how well you know your process, because if you have a good understanding of your design space you may use your "low complexity PATs" such as temperatures, pressures, flow rates to demonstrate your process is under a state of control and when it's not. Still, I would like to know if anyone has a different opinion / experience on this.
I agree with both of you regarding the use of basic sensors like temperature and mass flow controllers as PAT tools. These sensors remain integral part of CM process, regardless of whether advanced PAT tools are implemented or not, as they serve as fundamental CPPs that affect CQAs in API CM. Based on my personal experience and knowing the dynamic nature of the CM process, I feel the use PAT tools, especially during development stage or kilo scale up proves beneficial in gaining deeper understanding into process dynamics and establishing the design space. Once a robust design space is established, it may be possible to reduce or eliminate the use or reliance on the PAT tools during commercial manufacturing.
